Components of DTaP Vaccine	Excipients Table Allergens Table Components Table
Indication To prevent infection with Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis Proprietary Name Tripedia Infanrix DAPTACEL Manufacturer sanofi pasteur GlaxoSmithKline sanofi pasteur Viability Inactivated bacterial vaccine Inactivated bacterial vaccine Inactivated bacterial vaccine Microorganism Bordetella pertussis, Corynebacterium diphtheriae, Clostridium tetani Bordetella pertussis, Corynebacterium diphtheriae, Clostridium tetani Bordetella pertussis, Corynebacterium diphtheriae, Clostridium tetani Dose 0.5 mL 0.5 mL 0.5 mL Route Intramuscular Intramuscular Intramuscular Dose form Suspension Suspension Suspension Appearance Homogenous white suspension after shaking Turbid white suspension after shaking White homogeneous cloudy suspension after shaking Concentration (per 0.5  mL)   Diphtheria, 6.7 Lf u Tetanus, 5 Lf u Pertussis toxin (PT), 23.4 mcg; Filamentous Hemaglutinin (FHA), 23 mcg Diphtheria, 25 Lf u Tetanus, 10 Lf u Pertussis: PT, 25 mcg; FHA, 25 mcg; Pertactin, 8 mcg  Diphtheria, 15 Lf u Tetanus, 5 Lf u PT, 10mcg;FHA, 5mcg; Pertactin, 3mcg; Fimbriae types 2 and 3, 5 mcg Preservatives/dose Thimerosal, ≤0.3 mcg 2-Phenoxyethanol, 2.5 mg 2-Phenoxyethanol, 3.3 mg (0.6% v/v) Adjuvant Aluminum potassium sulfate, ≤0.17 mg Aluminum Hydroxide, ≤0.625 mg Aluminum Phosphate, 0.33 mg Excipients Formaldehyde, ≤100 mcg Gelatin Polysorbate 80 Formaldehyde, ≤100 mcg Polysorbate 80, ≤ 100 mcg Sodium chloride, 4.5 mg/mL Formaldehyde, ≤0.1 mg Glutaraldehyde, ≤50 ng Allergens Stopper vial may contain dry natural latex rubber Stopper vial may contain dry natural latex rubber Stopper vial may contain dry natural latex rubber Media       Bordetella pertussis Stainer-Scholte modified by casamino acids and dimethyl-beta-cyclodextrin Modified Stainer-Scholte liquid medium Stainer-Scholte medium Modified by Casamino Acids and Dimethyl-beta-cyclodextrin Corynebacterium diphtheria Modified Mueller’s growth medium Detoxified using formaldehyde Purified using serial ammonium sulfate fractionation and diafiltration Fenton medium containing bovine extract Detoxified using Formaldehyde PT detoxified using Glutaraldehyde FHA and Pertactin detoxified using formaldehyde Modified Mueller’s growth medium Purified using  Ammonium Sulfate Fractionation. Detoxified using Formalin   Clostridium tetani Peptone-based medium containing a bovine extract Detoxified using formaldehyde Purified using serial ammonium sulfate fractionation and diafiltration Modified Lantham medium derived from bovine casein Detoxified using formaldehyde Mueller-Miller Casamino acid medium Detoxified using formalin Purified by Ammonium Sulfate fractionation Packaging 0.5 mL vials 0.5 mL vials and disposable prefilled syringes 0.5 mL vials Routine Storage 2 to 8° C (35-46° F) Do not freeze 2 to 8° C (36-46° F) Do not freeze 2 to 8° C (35-46° F) Do not freeze updated July 2005
This page was last updated on January 23, 2008 © 2005 Institute for Vaccine Safety